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Company Statement

Biocon Facility Completes Pre Approval U.S. FDA Inspection

Bengaluru, India, Mar 06, 2019

"This is to inform you that the U.S. FDA concluded a pre-approval inspection of Biocon's insulin drug substance manufacturing facility triggered by a New Drug Application submitted by our insulin API customer.

The inspection at the Bengaluru facility took place between 25th Feb - 5th Mar, 2019, resulting in a Form 483 with six observations.

Biocon is confident of addressing these expeditiously and remains committed to global standards of Quality and Compliance"

- Company Spokesperson

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